Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-25 @ 2:31 AM
NCT ID:
NCT05769634
Eligibility Criteria:
Inclusion Criteria:
* Epileptologists at Mount Sinai West have identified the patient as having drug-resistant epilepsy that may benefit from surgery
* Patient has or will undergo invasive monitoring as part of routine surgical management
* Patient has or will be implanted with a minimum of 6-8 bilateral SEEG pairs, including posterior and anterior insula, and at least four of the following targets:
* ventral lateral prefrontal cortex
* dorsal medial prefrontal cortex
* mid-cingulate
* subcallosal cingulate
* amygdala
* hippocampus
* fusiform gyrus
* Sufficient use of hands to complete self-report questionnaires and tasks, as determined during pre-surgical neuropsychological assessment
* Normal or corrected to normal vision, determined by patient report
* Use of anti-epileptic drugs (AEDs) with known psychiatric complications will not be an exclusion criterion
Exclusion Criteria:
* Pre-operative neuropsychological testing indicates a Montreal Cognitive Assessment (MOCA) score \< 26.
* English language proficiency insufficient to complete psychometric questionnaires and receive task instructions (\<6th grade reading level) as determined by neuropsychologist at pre-operative assessment
* Vulnerable populations such as minors, pregnant women, cognitive impaired individuals and prisoners will not be included in the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05769634
Study Brief:
Protocol Section:
NCT05769634